Home | Databases | WorldLII | Search | Feedback Indian Parliamentary Research Service Legislative Summaries

The Clinical Establishments (Registration and Regulation) Bill, 2007 - Legislative Brief [2007] INPRSLS 8 (30 August 2007)

Legislative Brief

The Clinical Establishments (Registration and Regulation) Bill, 2007

The Bill was introduced in the Lok Sabha on August 30, 2007.

The Bill has been referred to the Standing Committee on Health and Family Welfare (Chairperson: Shri Amar Singh), which is scheduled to submit its report within three months.

Highlights of the Bill

• The Clinical Establishments (Registration and Regulation) Bill, 2007 seeks to register and regulate, and set standards for clinical establishments. It shall be applicable to all union territories and four states. Other states may adopt the Bill.

• A clinical establishment is defined as a hospital, maternity home, nursing home and any similar facility with beds. The definition also includes a laboratory that carries out pathological, bacteriological and other diagnostic services.

• The central government shall establish a National Council. Its main functions include prescribing standards for clinical establishments and maintaining a register of clinical establishments.

• Every clinical establishment will need to register. The Bill provides for both provisional registration and permanent registration upon satisfaction of prescribed conditions.

• The district registering authority is responsible for registering clinical establishments, inspecting such establishments and cancelling registrations in case of non-compliance with prescribed standards.

Key Issues and Analysis

• The definition of “clinical establishment” refers to dispensaries and clinics; however it also states that the facilities should have beds. This would arguably exclude clinics which only provide out-patient services.

• In case of change of ownership or management, the clinical establishment will need a new registration. This requirement differs from other sectors in which the registering authority is informed and the transfer is recorded in the register.

• The regulator for all clinical establishments (including government establishments) at the district level is also the administrator for government health services. This could lead to conflict of interest.

• The Bill stipulates that a register has to be maintained in digital format. This could prevent the use of new technologies which might not be digital in nature.

• The Bill is not applicable in areas where eight state Acts have jurisdiction. These Acts do not cover all the different types of clinical establishments listed in the Bill.

Recent Briefs:

The Private Detective Agencies (Regulation) Bill, 2007

November 2, 2007

The Judges (Inquiry) Bill, 2007

October 3, 2007

Kaushiki Sanyal

kaushiki@prsindia.org

November 13, 2007

PRS Legislative Research  Centre for Policy Research  Dharma Marg  Chanakyapuri  New Delhi – 110021

Tel: (011) 2611 5273-76, Fax: 2687 2746

PART A: HIGHLIGHTS OF THE BILL¹

Context

Since “public health and sanitation, hospitals and dispensaries” fall under the purview of the State List in the Indian Constitution, only states can enact a law on the subject. Some states have enacted laws for regulating clinical establishments. For example, Delhi Nursing Homes Registration Act, 1953 and the Tamil Nadu Private Clinical Establishment Act, 1997. These laws either lack effective implementation or have varying minimum standards.² Also, some of them do not cover laboratories and diagnostic centres.Error: Reference source not found

One of the goals of the National Health Policy 2002 was to enact a law to regulate minimum infrastructure and quality standards in clinical establishments by 2003.³ A working group set up by the Planning Commission also recommended the enactment of legislation for registration and regulation of clinical establishments.Error: Reference source not found

The Clinical Establishments (Registration and Regulation) Bill, 2007 was introduced in Parliament to ensure uniform standards of facilities and services in clinical establishments. Four states, Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, have passed resolutions empowering the Parliament to legislate on the issue. The Bill lists eight Acts⁴ and says that it is inapplicable in states where these laws are valid.

Key Features

Applicability

• The Bill shall be applicable to all union territories and four states (Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim). Other states may adopt the law by passing a resolution in the state legislatures.

Regulation of Clinical Establishments

• The Bill seeks to register and regulate clinical establishments. “Clinical establishment” is defined as hospitals and clinics and similar facilities with beds that offer diagnosis or treatment for illness or injury or pregnancy in any recognised system of medicine (allopathy, yoga, naturopathy, ayurveda, homoeopathy, siddha and unani). It also includes any laboratory which offers pathological, chemical and other diagnostic services. An establishment can be owned by the government, a trust, a corporation (including a cooperative society), a local authority and a single doctor establishment. The Bill does not apply to any clinical establishment owned or managed by the Armed Forces.

the National Council). The state government shall designate the District Health Officer or the Chief Medical Officer as the district registering authority for clinical establishments.

• The central government shall notify standards for each type of clinical establishment. The Bill provides for a system of provisional and permanent registration. The provisional registration is valid for a period of one year. These may be granted till three years after the central government notifies minimum standards for that type of establishment. After that period, only permanent registration may be granted.

• Existing clinical establishments have to apply for registration within one year from the date of commencement of the Act. Irrespective of registration under any existing law, every clinical establishment has to register under the Act. The registering authority is required to grant provisional registration within 10 days of receiving the application. No inquiry is required before granting of such provisional registration.

• A clinical establishment, applying for permanent registration, has to submit evidence of it having complied with the prescribed minimum standard. The information shall be displayed for 30 days for any objection to be filed. Permanent registration shall be granted only when a clinical establishment fulfils the prescribed standards for registration. A clinical establishment can reapply even if its application has been rejected.

Inspection of Clinical Establishments

• The registering authority may authorise an inspection or an inquiry of any clinical establishment. The clinical establishment shall have the right to be represented during the inspection or inquiry. The authority shall convey its views and may advise the establishment on the action to be taken.

• A show cause notice may be issued if the authority feels that a clinical establishment is not complying with the conditions of its registration or the person managing the establishment has been convicted of an offence punishable under the Act. The authority may cancel the establishment’s registration if it feels there is a breach of the law. The authority may enter and search in the prescribed manner after giving notice of its intention to the clinical establishment, if it suspects that an establishment is operating without registration.

Appeal

• Any person aggrieved by the order of the registering authority refusing to grant or renew registration or revoking a certification of registration may appeal to the state government.

Penalties

• If anyone operates a clinical establishment without registration, he shall on first conviction be punishable with fine up to Rs 50,000, on second offence with fine up to Rs 2 lakh and for any subsequent offence with fine up to Rs 5 lakh. If someone knowingly serves in a clinical establishment which is not registered he shall be punishable with fine up to Rs 25,000. If any person violates the provisions of the Act and no penalty is provided elsewhere, he shall be punishable with fine up to Rs 10,000 for the first offence. For a second offence, the fine may extend to Rs 50,000 and for any subsequent offence it may extend to Rs 5 lakh.

Finances

• The expenditure to set up the machinery for enacting the provisions of the Act shall be borne by the Central Government. It could involve recurring and non-recurring expenditure from the Consolidated Fund of India. The estimated total expenditure per annum is Rs 60 lakh.

PART B: KEY ISSUES AND ANALYSIS

Exclusion of Out-Patient Clinics

T

Clause 2(c)(i)

I

Clause 11

The definition of a clinical establishment appears to exclude dispensaries, clinics etc without beds, i.e., those that deal only with out-patients. Since private out-patient facilities constitute 60-70 per cent of the private sector health care in India,Error: Reference source not found the purpose of the Bill to register and regulate all clinical establishments might not be served if such establishments are excluded from its purview.

T

Clause 20

ransfer of Ownership

The Bill requires a clinical establishment to apply for fresh registration in case of transfer of ownership or management. This requirement differs from the case of transfer of ownership in several other cases, in which the registering authority is informed and the transfer is recorded in the register. (For example, if A sells a car to B, the registration number remains the same, but the ownership is changed by informing the registration office).

Furthermore, in case of a clinical establishment which is registered as a company and trades on the stock exchanges, the ownership structure changes every time the stock trades. This provision would imply that a new registration is required on each such instance.

Conflict of Interest

T

Clauses

Format of register

T

Clause 37

The Information Technology (Amendment) Bill, 2006⁵ aims to amend the Information Technology Act by changing all references from “digital signature” to “electronic signature”. The reason is to keep the option open for newer technologies.

State Acts and the Bill

T

Clause 56;